Thalidomide tragedy: Lesson learned in the past

Thalidomide disaster was one of the biggest disasters in pharmaceutical industry. Since mid fifties of the twentieth century, more than 10.000 children have been born with stunted arms and legs, and damaged internal organs. Today, many questions sill stand: Was the tragedy preventable? What were the main reasons for borning more than 4.000 thalidomide children in West Germany, and 17 in United States? We tried to answer these questions, by comparing thalidomide stories in West Germany and United States. In West Germany, law regulations were very flexible. Federal Health Office registered new drugs, but had no authority to withdraw a drug that was approved dangerous on the market. Analyzing the stories he heard from his patients and colleagues, pediatrician dr. Widunkind Lenz realized that Contergan® (brand name for thalidomide) was responsible for birth defects. Pharmaceutical company, Chemie Grunenthal developed thalidomide, but re- fused to withdraw drug from the market. It took years, until the trial started. Dr. Lenz was dismissed from trial, as biased. As a result of two years long trial, company and federal government established the fund for children injured by Contergan®. In United States, pharmacologist dr. Frances Kelsey had been employed in Food and Drug Administration (FDA). She was the one who received a new drug application for thalidomide. Realized that application was in- complete, she refused to approve application. Unlike dr. Lenz, law regulations and FDA stood behind her. Thalidomide has never been approved in United States, and Dr. Kelsey was promotioned. She was also awarded for preventing thalidomide to reach the market. By comparing these stories, we realize how are important ethics and regulations in approving new drugs and their withdrawing.